EDWARDS INTUITY Valve System CADENCE Study

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Disease; Aortic Stenosis

Treatments: Device: Stented aortic bioprostheses; Device: EDWARDS INTUITY

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688153

2011-11

Details and patient eligibility

About

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

Full description

This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• ≥18 years of age
• aortic stenosis / mixed aortic stenosis and aortic insufficiency
• SAVR+CABG (1-4 distal anastomoses)
• Log. EuroSCORE ≥6
• NYHA Class ≥II

Exclusion (i.a.):

• pure aortic insufficiency
• pre-existing prosthetic heart valve or ring
• congenital true bicuspid / unicuspid aortic valve
• LVEF <20%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

EDWARDS INTUITY

Active Comparator group

Description:

EDWARDS INTUITY Valve System, Model 8300A

Treatment:

Device: EDWARDS INTUITY

Stented aortic bioprostheses

Active Comparator group

Description:

Stented aortic bioprostheses

Treatment:

Device: Stented aortic bioprostheses